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Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device (CLEPSYDRA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sorin Group
Information provided by (Responsible Party):
ELA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00957541
First received: August 10, 2009
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.


Condition Intervention Phase
Congestive Heart Failure
 Device: Paradym CRT + Physiological Diagnosis (PhD)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by ELA Medical, Inc.:

Primary Outcome Measures:
  • Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee). [ Time Frame: Thirteen months ] [ Designated as safety issue: No ]
  • Mean number of false positives per patient per year. [ Time Frame: Thirteen Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: September 2009
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRT Therapy
All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
 Device: Paradym CRT + Physiological Diagnosis (PhD)
All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

Detailed Description:

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
  • Subject has severe heart failure (NYHA Class III or IV)
  • Subject has experienced at least one heart failure event within six months prior to enrollment
  • Subject continues to have heart failure symptoms despite receiving optimal medical therapy
  • Schedule for implant of a PARADYM CRT-D (Model 8770)
  • Subject has signed and dated an informed consent form

Exclusion Criteria:

  • Any contraindication for standard cardiac pacing
  • Any contraindication for ICD therapy
  • Abdominal implantation site
  • Hypertrophic or obstructive cardiomyopathy
  • Acute myocarditis
  • Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
  • Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
  • Correctable valvular disease that is the primary cause of heart failure
  • Mechanical tricuspid valve
  • Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intravenous infusion) more than twice per week
  • Heart transplant recipient
  • Renal insufficiency requiring dialysis
  • Already included in another clinical study
  • Life expectancy less than 12 months
  • Inability to understand the purpose of the study or refusal to cooperate
  • Inability or refusal to provide informed consent or HIPAA
  • Unavailability for scheduled follow-up at the implanting center
  • Known sensitivity to 1mg dexamethasone sodium phosphate (DSP)
  • Under guardianship
  • Age of less than 18 years
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957541

Locations
United States, Arizona
Mountain Vista Hospital
Mesa, Arizona, United States, 85209
Sponsors and Collaborators
ELA Medical, Inc.
Sorin Group
  More Information

Publications:

Responsible Party: ELA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00957541     History of Changes
Other Study ID Numbers: ITSY02
Study First Received: August 10, 2009
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ELA Medical, Inc.:
NYHA Class III or IV
Implantable Cardiac Defibrillator
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013